The United States Food and Drug Administration (FDA) inspected your facility, located at 156 Mott Street, Bsmt., NY, NY 10013, on October 11th and October 24th, 2018. During the inspection, we identified serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. Additionally, we have reviewed the label for your TR Zell P-Centa soft gels product collected during the inspection, as well as other product labeling. Based on our review, we have identified other serious violations of the Act. You can find the Act and the FDA regulations through links in FDA’s website at
www.fda.gov
(
http://www.fda.gov/
).
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website at the Internet address
www.trzell.com
in February 2019 and has determined that you take orders there for your product TR Zell P-Centa soft gels. The claims on your website establish that the product is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
- “TR Zell P-Centra are a highly concentrated and purified form of cell therapy . . .. Cell therapy is a specialized treatment that uses live cells to heal damaged organs throughout the body.”
- “Cellular therapy is a breakthrough in medical treatments that rehabilitates users by implanting new cells into the body. This process successfully remedies the symptoms while fighting the causes.”
- “16th Century – Heart heals heart, lung heals lung, spleen heals spleen; like cures like. – Paracelsus, Swiss German physician, founder of toxicology. Paracelsus believed that illnesses are treated more effectively with living tissue, unlike conventional medicines that helps rebuild after the original tissues have been broken.”
- “1912 - Physicians gave rise to cellular therapy when they employed thyroid cells to treat young patients suffering with hypothyroid. The procedure expedited in regenerating and healing organs, including adrenals, thyroid, pituitary gland, liver, kidney, ovaries, spleen, brain and the heart.”
- “1931 - Dr. Niehans would go on to utilize his studies in cellular therapy to successfully rejuvenate a removed parathyroid gland from an adult patient. This extended her life by 30 years, exceeding Dr. Niehans’ initial expectations.”
- “Many looked for treatment [with cellular therapy]…to cur[e] illnesses. During Dr. Niehans’ lifetime, he treated over 15,000 patients, with an exceptionally high success rate.”
- “Due to the efforts of Dr. Niehans and his successors in cell therapy, this procedure adapted the process of applying organ cells from medically prepped animal. Sheep are the ideal candidate for this procedure due to their natural tolerance to fatal diseases and toxins.” (Sheep placenta extract is listed as an ingredient in TR Zell P-Centra.)
- “Grapeseed Extract [an ingredient in TR Zell P-Centra] . . . Improves blood pressure, atherosclerosis, vision problems, swelling”
- Under your TR Zell page under the header “Benefits”:
- “Decreased risk of heart disease…”
- “Decreased cholesterol”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of TR Zell P-Centa soft gels for the cure, mitigation, or treatment of disease. Examples of such testimonials include:
- “I was diagnosed with Parkinson's Disease 5 years ago when I was 50 years old. I started the TR Zell P-Centa shortly after being diagnosed…When I went to my specialist, he was surprised that I am not progressing as fast as most of his patients with the small amount of medication I am taking. He wanted to know what I was taking as I really haven't changed much in the 5 years.”
- “I had a heart attack in 2015. After that I took TR Zell P-Centa for one year. The results in my body and my health was excellent. Today, I stopped my heart medications and all my body is better.”
- “I want to take this opportunity to thank TR Zell for helping me get pregnant successfully. I had three miscarriages before which were very painful experiences….I came across TR Zell, and this soft gel supplement helped me got pregnant successfully without a miscarriage.”
- “A few years ago I had a blood disorder complicated with anemia. I researched how beneficial TR Zell placenta soft gels products would be for many regenerative health problems. I ordered your product and within 2 weeks I saw a big difference. I felt better than I ever felt in my life during those 6 months when I took the placenta pills.”
Your TR Zell P-Centa soft gels product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)]), can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your TR Zell P-Centa soft gels product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment. Therefore, it is impossible to write adequate directions for a layperson to use this product safely for its intended purposes. Accordingly, your TR Zell P-Centa soft gels product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
Even if your TR Zell P-Centa soft gels product did not have therapeutic claims that make it an unapproved new drug and misbranded drug, this product would be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the product has been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. The October 11th & 24th, 2018, inspection of your facility revealed significant violations of the CGMP requirements for dietary supplements.
We have received your response, dated November 14, 2018, concerning the CGMP observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm on October 24th, 2018. We address this response below, in relation to each of the noted violations.
Your significant CGMP violations are as follows:
- You failed to conduct quality control operations for packaging and labeling operations, including approving for release, or rejecting, any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h). Specifically, you do not perform quality control functions, such as reviewing documentation from the manufacturers with whom you contract relating to how the products you release into commerce are manufactured and whether they conform to established specifications, in order to approve and release the products for distribution.
- As a dietary supplement distributor that contracts with a manufacturer to manufacture a dietary supplement that you distribute under your firm’s name, you have an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [see 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery of, dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of those products are in compliance with dietary supplement CGMP requirements.
Although a firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)). The Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331(a)). Thus, a firm that enters a contract with other firms to conduct certain dietary supplement manufacturing, packaging, and/or labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
You receive (b)(4) packaged dietary supplements from a contract manufacturer that manufactures the dietary supplement on your behalf, which you package, label, hold, and distribute into interstate commerce. As such, quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). As you perform such operations, you must make and keep written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements, in accordance with 21 CFR 111.140(b)(2).
Your written response dated November 14, 2018 does not address this violation.
- You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distribution operations. You have created a procedure entitled “Procedures for Holding and Distribution Operations,” which speaks to how you create, maintain, and revise specification sheets, but this procedure does not establish procedures for holding and distributing operations; neither do you have any other written procedures for holding and distribution operations. Once you establish such written procedures for holding and distribution operations, you must make and keep records of these written procedures, as required by 21 CFR 111.475(b)(1).
We have reviewed your written response dated November 14, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states that you will establish procedures for holding and distributing operations; however, you did not provide any procedures or supporting documentation.
- You failed to establish and follow written procedures for the review and investigation of product complaints, as required by 21 CFR 111.553, and in accordance with 21 CFR 111.560. Specifically, you have not established written procedures for the review and investigation of product complaints. Once you have established such written procedures, you must make and keep records of your compliance with such requirements for product complaints, in accordance with 21 CFR 111.570(b)(2).
We have reviewed your written response dated November 14, 2018. Your response states that you will create a complete product complaint program with detailed instructions and provide a toll-free number for customer to call. We are unable to evaluate the adequacy of your corrective action because you did not provide documentation to support that you have established a written procedure for how you review and investigate product complaints.
- You failed to establish specifications to provide sufficient assurance that the product you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with the purchase order, as required by 21 CFR 111.70(f). Specifically, you failed to establish specifications to ensure that the (b)(4) shipments of TR Zell P-Centa Forte received for repackaging and labeling, and for distribution rather than return to the supplier, are adequately identified and consistent with the purchase order.
Your written response dated November 14, 2018 does not address this violation.
- You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d). Specifically, you have not established packaging and labeling specifications for your TR Zell P-Centa Forte dietary supplement product.
We have reviewed your written response dated November 14, 2018. Your response states that you will establish packaging and labeling specifications. We are unable to evaluate the adequacy of your corrective action because you did not provide documentation to support that you have established packaging and labeling specifications for your TR Zell P-Centa dietary supplement product.
- You failed to establish written training procedures, as required by 21 CFR 111.8. Specifically, you have not established any written training procedures.
Your written response dated November 14, 2018 does not address this violation.
Misbranded Dietary Supplements
Further, even if the labeling for your TR Zell P-Centa soft gels product did not make therapeutic claims which make the product an unapproved new drug and misbranded drug, this product would be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and FDA’s implementing regulations at 21 CFR part 101, as follows:
- Your TR Zell P-Centa soft gels product is misbranded with the meaning of section 403(a)(1) Act [21 U.S.C. § 343(a)(1)] in that the product labeling is false or misleading in any particular. The product label asserted that it is “produced in FDA approval [sic] manufacturing plant.” This statement is false in that FDA does not approve manufacturing plants.
- Your TR Zell P-Centa soft gels product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the label fails to identify the species of fish from which the dietary ingredients fish protein and fish collagen are derived, as required by the Food Allergen Consumer Protection Act.
- Your TR Zell P-Centa soft gels product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because it is a dietary supplement but does not include a statement of identity as a “dietary supplement” or an appropriately descriptive term indicating the type of dietary ingredients that are in the product, as required by 21 CFR 101.3(g). Your TR Zell P-Centa includes a statement of identity as an “Optimised Food Supplement.” Generic terms that are not descriptive, such as “Food Supplement,” are not appropriate because they do not identify or describe the dietary ingredients or combination of ingredients that the product supplies (see Vol. 62 Federal Register 49826, 49827).
- Your TR Zell P-Centa soft gels product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for your TR Zell P-Centa soft gels product does not include a complete address or phone number.
- Your TR Zell P-Centa soft gels product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7.
- Your TR Zell P-Centa soft gels product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example:
- The product label declares calories with an amount of 0. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared in accordance with 21 CFR 101.36(b)(2)(i).
- The product label bears an incorrect % Daily Value for vitamin E based on the quantitative amount of 20 mg that is declared per serving, in accordance with 21 CFR 101.36(b)(2)(iii). Furthermore, the Daily Value must be expressed to the nearest whole percent.
- The product label lists Vitamin E in the wrong order. Vitamin E is a (b)(2)-dietary ingredient, and therefore, it must be listed above a heavy bar before "other dietary ingredients" in accordance with 21 CFR 101.36(b)(3)(i) and 101.36(e)(6)(ii).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, the FDA may assess fees to cover any reinspection-related costs.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
